Vive DMD1001 Operation & User’s Manual

DMD1001 Arm Type Thank you very much for selecting VIVE™ Digital Blood Pressure Monitor DMD1001 Please read the user manual carefully and thoroughly to ensure the safe usage of this product, and retain the manual for reference in case you have problems. WWW.VIVEHEALTH.COM Contact us 24/7 at www.vivehealth.com

Monitor Components BEFORE YOU START...........................................................................................................6 The Choice of Power Supply Installing and Replacing the Batteries Measurement Principle Setting Date, Time and Measurement Unit MEASUREMENT...................................................................................................................9 Tie the Cuff Select the User Start the Measurement DATA MANAGEMENT..........................................................................................................12 Recall the Records Delete the Records INFORMATION FOR USER................................................................................................15 Tips for measurement Maintenances ABOUT BLOOD PRESSURE..............................................................................................17 What are systolic pressure and diastolic pressure? What is the standard blood pressure classification? Why does my blood pressure fluctuate throughout the day? Why the blood pressure I get from the hospital is different from home? If the result is the same if measuring on the right arm? TROUBLESHOOTING.........................................................................................................19 SPECIFICATIONS...............................................................................................................20 AUTHORIZED COMPONENT ............................................................................................21 CONTACT INFORMATION..................................................................................................21 COMPLIED STANDARDS LIST...........................................................................................22 FCC STATEMENT...............................................................................................................22 EMC GUIDANCE.................................................................................................................23 Table of Contents CATALOG

They are the requirement of standard and using. Symbol for “THE OPERATION GUIDE MUST BE READ” Symbol for “MANUFACTURER” Symbol for “SERIAL NUMBER” Symbol for “TYPE BF APPLIED PARTS” Symbol for “DIRECT CURRENT” Symbol for “ENVIRONMENT PROTECTION - Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice” Thank you for selecting VIVE™ upper arm Blood Pressure Monitor (DMD1001). The monitor features blood pressure measurement, pulse measurement, and result storage. The design provides you with two years of reliable service. Readings taken by the DMD1001 are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method. This manual contains important safety and care information, and provides step-by-step instructions for using the product. Read the manual thoroughly before using the product. Features: Maximum 60 records per each user General Description 3rd technology: Measuring during inflation (Most up to date technology in the world) 2.4x1.6in Digital LCD display INTRODUCTION INTRODUCTION CAUTION This device is intended for adult use only. This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement. Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure. Do not begin or end medical treatment. Consult your physician for treatment or advice. If you are taking medication, consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your physician. If the cuff pressure exceeds 40kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressure exceeds 40 kPa (300 mmHg), detach the cuff from the arm and press the START/STOP button to stop inflation. To avoid measurement errors, carefully read this manual before using the product. The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide. The operator shall not touch output of batteries and the patient simultaneously. To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal when using the AC adaptor. The user must check that the equipment functions safely and see that it is in proper working condition before being used. Please use ACCESSORIES and detachable parts specified/ authorized by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/ patients. Manufacturer will make available on request circuit diagrams, component parts list, etc. This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patient’s arm and fingers will become anesthetic, swollen and even purple due to a lack of blood. Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced. During using, the patient will contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential allergic reaction or contact injury. The device doesn’t need to be calibrated in two years of reliable service. Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines. When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or arterial fibrillation, the best result may occur deviation. Please consult your physician about the result. The device is contraindicated for any female subject who may be suspected of, or is pregnant. Besides provided inaccurate readings, the effects of this device on the fetus are unknown. When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: Too frequent and consecutive multiple measurements; The application of the cuff and its pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; Inflating the cuff on the arm on the side of a mastectomy. Do not apply the cuff over a wound, otherwise it can cause further injury. Do not inflate the cuff on the same limb which other monitoring ME EQUIPMENT is applied around simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME EQUIPMENT. Using it in case to result in prolonged impairment of the circulation of the blood of the PATIENT. Don’t kink the connection tube, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT. The device has been evaluated clinically used manual cuff/stethoscope auscultations the reference. Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed Symbol for “MANUFACTURE DATE”

SYMBOL DESCRIPTION Systolic blood pressure High pressure result Diastolic blood pressure Low pressure result EXPLANATION Pulse per minute Beats per minute, BPM Deflating Air in cuff is deflating Memory The displayed measurement values stored in the memory. mmHg kPa Measurement Unit of the blood pressure Measurement Unit of the blood pressure Low battery Batteries are low and need to be replaced Irregular heartbeat Arrhythmia Grade The grade of the blood pressure kPa mmHg Current Time Month/Day/Year, Hour/Minute INTRODUCTION Monitor Components List 1.Blood Pressure Monitor (TMB-1491-D) 4.User manual 2.Cuff (Type BF applied part) (22~32cm) Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve 3. 4×AAA batteries BATTERY COMPARTMENT CUFF AIR HOSE AIR CONNECTOR PLUG LCD DISPLAY MEM BUTTON START/STOP BUTTON SET BUTTON INTRODUCTION User 1 User 2 Start measurement and save the results for User 1 Start measurement and save the results for User 2

BEFORE YOU START In order to get the best effect and protect your monitor, please use the right battery and special power adapter which complies with U.S. safety standard. • Open the battery cover. • Install the batteries by matching the correct polarity, as shown. • Replace the cover. Installing and Replacing the Batteries CAUTION Remove batteries if the device is not likely to be used for some time. The old batteries are harmful to the environment, so please DO NOT dispose with other daily trash. Remove the old batteries from the device and follow your local recycling guidelines. CAUTION Replace the batteries when: (See Below) The shows The display dims The display does not light up Do not dispose of batteries in fire. Batteries may explode or leak. AC adaptor (Not Included) The Choice of Power Supply 1.Battery powered mode: 6VDC 4×AAA batteries 2.AC adaptor powered mode: 6V 1A (Please use the recommended AC adaptor model). (Not Included) Please unplug the adaptor when not in use. Measurement Principle Setting Date, Time and Measurement Unit It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (The setting range of the year: 2014—2054 time format:12 H) This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a “zero pressure” equivalent to the air pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval then calculates standard deviation. The device will display a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%. 1.When the monitor is off, hold pressing “SET” for 3 seconds to enter the mode for year setting. Or when the monitor is off, press “SET” button shortly, it will display the time. Then hold pressing “SET” button to enter the mode for year setting. 2.Press the “MEM” to change the [YEAR].Each press will increase the numeral by one in a cycling manner. 3.When you get the right year, press “SET” to set down and turn to next step.

MEASUREMENT 4.Repeat step 2 and 3 to set the [MONTH] and [DAY]. 5.Repeat step 2 and 3 to set the [HOUR] and [MINUTE]. 7.After the unit is set, the LCD will display “done” first, then display all the settings you have done and then it will turn off. 6.Repeat step 2 and 3 to set the [UNIT]. Resting For 5 minutes before measuring. Wait at least 3 minutes between measurements. This allows your blood circulation to recover. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, position of upper arm, or as directed by a physician. Applying the cuff 1.Apply the cuff on your upper arm. Make sure the position of the tube is off-center; toward the inner side of arm in line with the little finger. 2.The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm. 3.Sit comfortably with your test arm resting on a flat surface. 2~3cm START STOP .Patients with Hypertension: The middle of the cuff should be at the level of the right atrium of the heart; Before starting measurement, please sit comfortably with legs uncrossed, feet flat on the floor, back and arm supported. 4

selecting the User ID, press the “START/STOP” button to turn on the monitor when the LCD is off, and it will finish the whole measurement. (Take User 1 for example.) Adjust the zero. LCD display Inflating and measuring. Display and save the results. Start the Measurement 2.Press the “START/STOP” to power off, otherwise it will turn off within 1 minute. START STOP START STOP MEASUREMENT Select the User 1.When the monitor is off, press SET button to turn on the monitor. Press SET button again to select the User ID between User 1 and User 2. 2.When the desired User ID is shown, press START/STOP button to confirm and the monitor will turn off. (Take User 1 for example.) START STOP

1. When the monitor is off, press the “MEM” to show the average value of the latest three records for the selected user. (Take User 1 for example.) 2. Press “MEM” button or “SET” button to rotate the history records. Press “MEM” button to review the record from the latest to the oldest. Press “SET” button to review the record from the oldest to the latest. The most recent record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped from the list. The current No. is No 2. The corresponding time is P.M. 10:08. The corresponding date is January 1st. CAUTION DOWN UP The date and time of the record will be shown alternately. 3. If you want to check another user’s records, press START/STOP button to turn off the monitor when it is in the memory recall mode. Then press “SET” button to turn on the monitor, press “SET” button again to select the desired user ID, when it displays your desired user ID, press START/STOP button to confirm, the LCD will turn off. Then press “MEM” button to review the selected user’s records. DATA MANAGEMENT 4. If there is no record, the following display will be shown. (Take User 1 for example.)

If you did not get the correct measurement, you can delete all results by following the steps below. Delete the Records 1.Hold pressing “MEM” and “SET” button for 3 seconds when the monitor is in the memory recall mode, the flash display “dEL ALL” will be shown. 2.Press “SET” button to confirm deleting and the LCD will display “dEL dOnE”, and then turn off. 3.If you don’t want to delete the records, press “START/STOP” button to escape. START STOP Tips for Measurement Within 1 hour after dinner or drinking Within 20 minutes after taking a bath In a very cold environment Immediate measurement after tea, coffee, smoking When talking or moving your fingers When you need to urinate It can cause inaccuracy if the measurement is taken in the following circumstances.

Maintenance In order to get the best performance, please follow the instructions below. Keep monitor in a dry place and avoid direct sunlight. Avoid intense shaking, collision, and shock. Use a damp cloth to wipe down monitor. DO NOT use corrosive cleaning chemicals, as they may damage device. Keep away from water. Avoid harsh environments. Do not attempt to clean the reusable cuff with water and never immerse the cuff in water. Please use ACCESSORIES and detachable parts specified/ authorized by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients. The device doesn’t need to be calibrated in two years of reliable service. Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines. If you have any problems with this device, such as setting up, maintaining or using, please contact [email protected]. Don’t open or repair the device by yourself. Please report to vivehealth.com if any unexpected operation or events occur. Please use a soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners. CAUTION ABOUT BLOOD PRESSURE What is systolic pressure and diastolic pressure? press artery vein blood discharging Systolic relax blood entering Diastolic When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure. What is the standard blood pressure classification? Irregular Heartbeat Detector This Blood Pressure Monitor is equipped with an intelligent function of Irregular Heartbeat (IHB) Detector. During each measurement, this equipment records the heartbeat intervals and works out the standard deviation. If the calculated value is larger than or equal to 15, this equipment will light up the IHB symbol on the screen when displaying the measuring result. CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart-beat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage. Only a physician can tell your normal BP range. Please contact a physician if your measuring result falls out of the range. Kindly note that only a physician could tell whether your blood pressure value has reached a dangerous point. The chart on the right is the standard blood pressure classification published by American Heart Association (AHA). CAUTION Blood Pressure Category Normal Prehypertension High Blood Pressure (Hypertension) Stage 1 High Blood Pressure (Hypertension) Stage 2 Hypertensive Crisis (Emergency care needed) Systolic mmHg (upper#) Diastolic mmHg (lower#) less than 120 120-139 140-159 160 or higher Higher than 180 and or or or or less than 80 80-89 90-99 100 or higher Higher than 110 AHA Home Guideline for This chart reflects blood pressure categories defined by American Heart Association. Upper Limit of Normal BP SYS 135 mm Hg DIA 85 mm Hg

TROUBLESHOOTING 1. Individual blood pressure can change on a daily basis. It is also affected by the way you apply the cuff and the measurement position. Please take measurements using the same method to ensure accuracy. 3.Waiting at least 3 minutes for another measurement. Why does my blood pressure fluctuate throughout the day? Can the results be different while taking measurement from right arm? You may choose to measure both arms and then average the two readings to get your blood pressure result. The norm is to measure the left arm closest to your heart. For accuracy use the same method each time. Why the blood pressure I get from the hospital is different from home? Blood pressure can fluctuate over a period of 24 hours based on: weather, emotions, exercise, stress, etc. When you take your blood pressure at home, make sure to pay close attention to the following: You had better take 2-3 deep breaths. Advice: Wait at least 4-5 minutes until you calm down. 2.The variations in the pressure can be greater or smaller, depending on the actual medicine taken. START STOP START STOP This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor. If the product is not operating as you think it should, please check troubleshooting below before arranging for service. PROBLEM SYMPTOM CHECK THIS REMEDY No power Low batteries Error message Display will not light up. Batteries are exhausted. Replace with new batteries Insert the batteries correctly Replace with new batteries Batteries are inserted incorrectly. Display is dim or show Batteries are low. E 1 shows The cuff is not secure. Refasten the cuff and then measure again. E 2 shows The cuff is very tight E 3 shows The pressure of the cuff is excess. Relax for a moment and then measure again. E10 or E11 shows E20 shows The measurement process does not detect the pulse signal. Loosen the clothing on the arm and then measure again EExx,shows on the display. A calibration error occurred. Retake the measurement. If the problem persists, contact the retailer or our customer service department for further assistance. Refer to the warranty for contact information and return instructions. E21 shows The treatment of the measurement failed. Relax for a moment and then measure again. AC adaptor is inserted incorrectly. Insert the AC adaptor tightly Readjust the cuff, not too loose or too tight and then measure again. The monitor detected motion, talking, or the pulse is too poor while measuring. Relax for a moment and then measure again. If the cuff is secured properly. If the cuff is too tight or too loose. If the cuff is secured on the upper arm. If you feel anxious.

Type BF applied part WARNING: No modification of this equipment is allowed. Temperature: -4°F to 140°F Relative Humidity 10%-93% Atmospheric Pressure: 50-106 kPa Temperature:40° to 104°F Relative humidity ≤85% Atmospheric pressure: 86kPa to 106kPa Power supply Battery powered mode: 6VDC 4×AAA batteries AC adaptor powered mode: 6V 1A (Please use the recommended AC adaptor model).(Not Included) Display mode Measurement mode Oscillographic testing mode Measurement range Measurement perimeter of the upper arm Net Weight Approx. 0.63lbs (Excluding the dry cells) External dimensions Attachment Mode of operation Continuous operation Degree of protection Protection against ingress of water IP21 Accuracy Normal working condition Storage & transportation condition Software Version V01 Pressure: Pressure:40°F to 104°F within±0.4kpa(3mmHg) pulse value:±5% Rated cuff pressure: 0kpa - 40kpa (0mmHg~300mmHg) Measurement pressure: 5.3kPa-30.7kPa (40mmHg-230mmHg) pulse value: (40-199) beat/minute Digital LCD 2.4x1.6in Digital LCD display Approx.4.3×4.3×1.6in 4×AAA batteries, user manual Contact Information For more information about our products, please visit www.vivehealth.com. You can get customer service, usual problems and customer download, VIVE™ will serve you anytime. Distributed by: © Copyright and Distributed by VIVE Health 5650 Yahl Street, Unit 1 Naples, FL 34109 All Rights Reserved. Made in China. vivehealth.com Email: [email protected] Authorized Component 1.Use the VIVE™ authorized adaptor. (Not Included) Adaptor Type：UE08WCP-060100SPA Input：100~240V，50~60Hz,400mA Output：6V 1A (Conforms to UL certificate) AUTHORIZED COMPONENT SPECIFICATIONS

Risk management Labeling User manual General Requirements for Safety Electromagnetic compatibility Performance requirements and Clinical Investigation Software life-cycle processes ISO/EN 14971:2012 Medical devices — Application of risk management to medical devices ISO/EN 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements EN 1041: 2008 Medical equipment manufacturers to provide information IEC 60601-1: 2005+A1：2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests IEC 80601-2-30:2009 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or automated sphygmomanometers IEC/EN 62304:2006+AC: 2008 Medical device software - Software life cycle processes FCC Statement This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. EMC Guidance 1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS 2. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d=3, 3m away from the equipment. (Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d=3, 3m at an IMMUNITY LEVEL of 3V/m) EMC GUIDANCE 22 23 COMPLIED STANDARDS LIST